Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System (ReMATCH)

April 29, 2026 updated by: Boston Scientific Corporation

The ReMATCH Study is a Prospective, Single Arm, Open Label, Multi-center, Study Utilizing the FARAPULSE PFA System, Including the FARAWAVE and FARAPOINT PFA Catheters

The ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to evaluate the safety and effectiveness of using the FARAWAVE™ and FARAPOINT™ pulsed field ablation (PFA) catheters for re-treatment of persistent atrial fibrillation (PersAF) after a failed initial procedure.

Study Type

Interventional

Enrollment (Estimated)

376

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Melbourne, Australia
        • Recruiting
        • The Alfred Hospital
        • Contact:
        • Principal Investigator:
          • Peter Kristler
    • New South Wales
      • New Lambton Heights, New South Wales, Australia, 606-8507
      • Westmead, New South Wales, Australia, 2145
    • Queensland
      • Brisbane, Queensland, Australia, 4001
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Parkville, Victoria, Australia, 3050
        • Recruiting
        • The Royal Melbourne Hospital
        • Principal Investigator:
          • Jonathan Kalman
        • Contact:
  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Li-Wei Lo, MD
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Yen-Bin Liu, MD
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36607
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Recruiting
        • Arrhythmia Research Group-Research Facility
        • Principal Investigator:
          • Devi Nair, MD
        • Contact:
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California Hospital
        • Contact:
        • Principal Investigator:
          • Ivan Ho, MD
      • Oxnard, California, United States, 93030
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University Medical Center
        • Contact:
        • Principal Investigator:
          • Alexander Perino, MD
    • Colorado
      • Littleton, Colorado, United States, 80120
        • Recruiting
        • South Denver Cardiology Associates, PC
        • Contact:
        • Principal Investigator:
          • Sri Sundaram, MD
    • Florida
      • Miami, Florida, United States, 33133
      • Naples, Florida, United States, 34102
        • Recruiting
        • Naples Comprehensive Health
        • Principal Investigator:
          • Dinesh Sharma, MD
        • Contact:
      • Orlando, Florida, United States, 32803
        • Not yet recruiting
        • AdventHealth Orlando-Hospital
        • Principal Investigator:
          • Naushad Shaik
        • Contact:
      • Tampa, Florida, United States, 33606
        • Not yet recruiting
        • Tampa General Hospital
        • Principal Investigator:
          • David Wilson
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Principal Investigator:
          • David Delurgio, MD
        • Contact:
      • Savannah, Georgia, United States, 31404
        • Recruiting
        • Memorial Health University Medical Center
        • Principal Investigator:
          • Todd Senn, MD
        • Contact:
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • St. Luke's Boise Medical Center
        • Contact:
        • Principal Investigator:
          • Marcos Daccarett, MD
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Not yet recruiting
        • Advocate Christ Medical Center-Hospital
        • Principal Investigator:
          • William Spear
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jonathan Chrispin, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Moussa Mansour, MD
        • Contact:
      • Fall River, Massachusetts, United States, 02720
        • Recruiting
        • Southcoast Physicians Group
        • Contact:
        • Principal Investigator:
          • Ramin Davoudi, MD
    • Michigan
      • Royal Oak, Michigan, United States, 48073
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center
        • Contact:
        • Principal Investigator:
          • Emily Zeitler, MD
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Recruiting
        • Virtua Health Inc.
        • Contact:
        • Principal Investigator:
          • Darius Sholevar, MD
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • Lovelace Medical Center
        • Contact:
        • Principal Investigator:
          • Yaw Adjei-Poku, MD
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health
        • Principal Investigator:
          • Jonathan Willner
        • Contact:
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medical University
        • Principal Investigator:
          • Jim Cheung
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Bethesda North Hospital
        • Contact:
        • Principal Investigator:
          • Marshall Winner, III, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Medical Center
        • Principal Investigator:
          • Salvatore Savona, MD
        • Contact:
    • Oklahoma
    • South Carolina
      • Charleston, South Carolina, United States, 29406
    • Texas
      • Austin, Texas, United States, 78705
      • Tyler, Texas, United States, 75701
        • Recruiting
        • CHRISTUS Trinity Mother Frances Health System
        • Contact:
        • Principal Investigator:
          • Stanislav Weiner, MD
    • Utah
      • Salt Lake City, Utah, United States, 84124
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk General Hospital
        • Contact:
        • Principal Investigator:
          • Divyang Patel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥ 18 years of age, or older if required by local law
  • Single previous endocardial AF ablation procedure for PAF or PersAF that minimally included pulmonary vein isolation
  • Documented (physician's note) diagnosis of PersAF either prior to the subject's Index Procedure OR development of PersAF after the Index Procedure.
  • Documented evidence of symptomatic AF recurrence at least 60 days after the subject's Index Procedure, captured by any regulatory cleared rhythm monitoring device.

OR

  • If diagnosed with PersAF prior to the Index Procedure, documented recurrence of symptomatic AF or atypical AFL at least 60 days after the Index Procedure, captured by any regulatory cleared rhythm monitoring device.
  • Willing and capable of providing informed consent
  • Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center

Exclusion Criteria:

  1. Atrial exclusions - Any of the following atrial conditions:

    a. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non-indexed volume >100 ml (physician note or imaging) b. Current atrial myxoma c. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible) d. Current left atrial thrombus

  2. Cardiovascular exclusions - Any of the following CV conditions:

    1. History of sustained ventricular tachycardia or any ventricular fibrillation
    2. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes

    3. Current or anticipated implantable cardioverter defibrillator, cardiac resynchronization therapy devices, or implantable loop recorders, other than LUX-Dx. Patients with a pacemaker are permitted; however, pacemaker-dependent patients are excluded.

      Prior interatrial baffle, atrial septal patch, atrial septal defect closure device, patent foramen ovale occluder Left atrial appendage closure devices are excluded, with the exception of WATCHMAN. WATCHMAN is excluded if implanted within 90 days of enrollment

    4. Presence of any of the following:

      • Any prosthetic heart valve, ring or repair

      • Moderate to severe mitral valve stenosis

      • More than moderate mitral regurgitation (>3+)

      • Moderate to severe aortic stenosis
    5. Hypertrophic cardiomyopathy
    6. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access
    7. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
    8. Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.

  3. Any of the following conditions at baseline:

    1. Heart failure associated with NYHA Class III or IV
    2. Documented LVEF < 40% as documented within the previous 12 months
    3. Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two (2) BP measurements at baseline assessment not attributable to white coat syndrome per Investigator opinion
    4. Body Mass Index (BMI) >45.0
    5. CHA2DS2-VASc score ≥5

  4. Any of the following events within 90 Days of the Consent Date:

    1. Coronary disease: Myocardial infarction (MI), unstable or Prinzmetal angina or coronary intervention within 90 days of consent or any documented history of severe non-revascularize coronary disease
    2. Cardiac surgery: Any cardiac surgery
    3. Heart failure hospitalization: Heart failure hospitalization
    4. Pericardium: Pericarditis or symptomatic pericardial effusion
    5. GI bleeding: Gastrointestinal bleeding
    6. Neurovascular event: Stroke, TIA, or intracranial bleeding
    7. Thromboembolism: Any active non-neurologic thrombus and/or thromboembolic event
    8. Carotid intervention: Carotid stenting or endarterectomy
    9. Diabetes: Uncontrolled diabetes mellitus or a recorded HgbA1c > 8.0%

  5. Any of the following congenital conditions:

    1. Congenital heart disease: Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
    2. Methemoglobinemia: History of known congenital methemoglobinemia
    3. G6PD deficiency: History of known G6PD deficiency

  6. Any of the following conditions:

    1. Transplantation: Solid organ or hematologic transplant, or currently being evaluated for a transplant
    2. Diaphragmatic abnormality: Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis.

    Pulmonary: Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen d. Renal: Renal insufficiency if an estimated glomerular filtration rate (eGFR) is < 30 mL / min / 1.73 m2, or with any history of renal dialysis or renal transplant e. Malignancy: Active malignancy (other than squamous cell carcinoma) f. Gastrointestinal: Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration g. Infections: Active systemic infection h. Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure i. Nitroglycerin intolerance: Known allergic drug reaction to nitroglycerin (excluding hypotension) j. Hematologic condition: Known coagulopathy or bleeding disorder (e.g. von Willebrand disease, hemophilia) k. Contraindication to anticoagulation: Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation.

    l. Pregnancy: Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period m. General health conditions: Health conditions that, in the investigator's medical opinion, would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.

    n. LUX-Dx ICM intolerance: Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device o. Participation in another trial: Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility.

    p. Life expectancy: Predicted life expectancy less than one (1) year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm Prospective
Repeat Ablation of Persistent Atrial Fibrillation, including Mitral Isthmus Catheter Ablation, with the FARAPULSE Pulsed Field Ablation System.
Device: FARAPULSE™ Pulsed Field Ablation System

The FARAPULSE™ Pulsed Field Ablation System is indicated for the treatment of symptomatic atrial fibrillation.

The FARAWAVE Catheter is indicated for the isolation of pulmonary veins and posterior wall in the treatment of drug-refractory, recurrent, symptomatic paroxysmal and persistent atrial fibrillation. The FARAWAVE Catheter is also indicated for the for the isolation of pulmonary veins and posterior wall in the treatment of persistent atrial fibrillation as an alternative to anti-arrhythmic drug (AAD) therapy as an initial rhythm control strategy.

The FARAPOINT™ PFA Catheter is indicated for use as an adjunctive device for 1) the creation of an ablation line between the inferior vena cava and the tricuspid valve and/or 2) Mitral Isthmus, when the FARAWAVE Catheter is used in the endocardial treatment of persistent atrial fibrillation (episode duration no greater than 12 months).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary safety endpoint rate
Time Frame: 60 days
The primary safety endpoint (PSE) is the proportion of Treatment subjects with one or more device or procedure-related Composite Serious Adverse Events (CSAEs) following the Repeat Ablation Procedure.
60 days
The primary effectiveness endpoint is the proportion of Treatment subjects with Acute Procedural Success.
Time Frame: 24 hours
The proportion of Treatment Subjects with confirmed electrical block across all anatomical locations ablated with the investigational system only (Acute Procedural Success).
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Moussa Mansour,, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

December 11, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

December 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PF313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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